The Effect of Micro-doses Erytropoietin on Exercise Capacity in Male and Females

University of Copenhagen

Status: Active, not recruiting

Conditions: Sports Drug Abuse

Treatments: Drug: EPO; Other: Control group - saline injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04965961

H-18013069

Details and patient eligibility

About

Recombinant human erythropoietin (rHuEPO) regimen enhances maximal oxygen consumption (VO2max), but the effect of micro-doses on maximal and submaximal performance is not clear and detection of micro-doses is difficult with current methods. This study investigated whether micro-doses of rHuEPO enhances maximal and endurance performance in males and females.

Full description

In a randomized, double-blind, placebo-controlled design, 48 trained adults (24 females, 24 males) receive either recombinant human erythropoietin (rHuEPO; epoetin-β, 9 IU/kg, n = 24, (12 females, 12 males)) or placebo (0,9% NaCl, n = 24, (12 females, 12 males)) three times per week for four weeks. Before the intervention, time trial performance and maximal oxygen uptake will be assessed. Three and five days after the last injection, time trial performance and maximal oxygen uptake will be determined to assess the effect of the rHuEPO administration. In addition, total hemoglobin mass and intravascular volumes will be determined via the carbon monoxide rebreathing method in duplicate measures.

Enrollment: 48 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Relative maximum oxygen uptake (VO2-max) of at least 50 ml O2/min/kg for male participants and 45 ml O2/min/kg for female participants

Exclusion criteria

• Age
• Insufficient fitness level
• Blood donation 3 months prior to enrollment
• Altitude exposure 2 months before enrollment
• Hypertension

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

48 participants in 2 patient groups, including a placebo group

Recombinant human erythropoietin treatment

Experimental group

Description:

Participants receive intravenous injections of 9 International Units per kg bodyweight epoetin-β (NeoRecormon, Roche, Mannheim, Germany) three times per week for four weeks on non-consecutive days. Subjects receive tablets with 80mg iron (Tardyferon, Pierre Fabre Pharme GmbH, Freiburg, Germany) to ensure sufficient iron stores for the expected increase in erythropoeisis.

Treatment:

Drug: EPO

Control group

Placebo Comparator group

Description:

Participants receive intravenous injections of \~0,5 mL saline (NaCl 0,9%) three times per week for four weeks on non-consecutive days.

Treatment:

Other: Control group - saline injection